Overview:
The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.
External US:
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
The Quality Assurance (QA) Operations Supervisor, will be responsible for the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
Reports to Senior Manager, Quality Assurance
Work Location College Station, TX
Primary Responsibilities:
- Supervise and provide direction to direct reports.
- Serve as TrackWise Administrator.
- Monitor and support site and global quality policies and procedures to ensure GMP compliance.
- Work with QA management to design and implement quality assurance training programs for staff development.
- Provide cGMP guidance to operations, QC and QA.
- Lead client audits and regulatory inspections.
- Utilize investigative techniques to determine root causes of deviations and proper corrective and preventative actions.
- Develop, motivate and lead direct reports towards achieving organizational and individual goals.
- Conduct periodic staff meetings.
- Review and/or approve basic and technical documentation to include, but not limited to:
- Standard Operating Procedures
- Batch Production Records (completed and approval)
- Commissioning, qualification and validation protocols and reports
- Deviation Reports
- Corrective Action/Preventive Action Plans
- Technical data review and approval
- QC data review and approval
- Drug Substance/Product Reports
- Manage Internal Quality audit functions to include, but not limited to:
- Audit of lab notebooks
- Audit of equipment logbooks
- Review of vendor, supplier, contract laboratory audit questionnaires
- Lead vendor, supplier, contract laboratory
- Identify process and Quality System improvement opportunities.
- Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Assist with compliance related functions.
- Work as a team member; be cooperative with all departments and staff to meet company objectives.
- All other duties as assigned.
Qualifications:
- Masters degree in a science-related field with 3+ years of related experience; OR
- Bachelors degree in a science-related field with 5+ years of related experience.
- 2+ years of supervisory or lead experience.
- 2+ years of cGMP experience.
- Certified Quality Auditor preferred.
- Degree in Biology or Chemistry preferred.
- Excellent written and oral communication skills.
- Excellent organizational, analytical, data review and report writing skills.
- Ability to set personal performance goals and provide input to departmental objectives.
- Develop staff to maximize contributions to the team and the company.
- Ability to multitask and easily prioritize work.
- Ability to work independently with little supervision.
- Proficient in Microsoft Excel, Word and PowerPoint.
- All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
- Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
- Lifting up to 25 pounds on occasion.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Must be willing to work flexible hours.
- Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
- Must be willing to travel occasionally, as needed.
- Attendance is mandatory.
Join us! FDB is advancing tomorrows medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.
We are an equal opportunity and affirmative action employer.? All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please email ...@fujifilm.com or call 979-###-####.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.